PresbyopiaNCT04883099
APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism
A study testing APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism in people with Presbyopia and Myopia, run by Lentechs, LLC at 6 sites in United States.
Trial summary
Vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the APIOC™ for Presbyopia or the APIOC™ for Presbyopia Astigmatism contact lenses. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Myopia, Hyperopia
- What is being tested?
- APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- 6 May 2021to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject must provide written informed consent.
- The subject must appear willing and able to adhere to the instructions set forth in this protocol.
- At least 40 years of age and no more than 70 years of age.
- ≤ 4.00 D of corneal astigmatism.
- ≤ 2.50 D of refractive astigmatism.
- Refractive error range +4.00 DS to -6.00 DS
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- Require a reading addition (bifocal) of at least 0.75 D
- Flat and steep keratometry readings within 40 to 48 D.
- Clear, healthy corneas with no irregular astigmatism.
- Normal, healthy conjunctiva in both eyes.
- Free of active ocular disease. Refractive error and presbyopia are permitted.
- Be a current or former (within the last 3 years) contact lens wearer.
- Best-corrected near and distance visual acuity better than or equal to 20/25.
Who cannot join
- Irregular corneal astigmatism.
- Corneal scarring unless off line-of-site and well healed.
- Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
- Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Occasional artificial tear use is permitted.
- Systemic disease that would interfere with contact lens wear.
- Currently pregnant or lactating (by self-report).
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- History of strabismus or eye movement disorder, including exophoria at near that is 4 D or greater than at far, and a receded near point of convergence break that is 6 cm or greater.
- Active allergies that may inhibit contact lens wear.
- Upper eyelid margin at or above the superior limbus.
- History of ocular or lid surgery.
- Immediate family members or significant others of doctors or staff at the clinical site.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Gaddie Eye Centers
Lexington, Kentucky, 40517
Miamisburg Vision Care
Miamisburg, Ohio, 45342
Vision Professionals
New Albany, Ohio, 43054
Eola Eyes
Orlando, Florida, 32803
Eyecare Professionals of Powell
Powell, Ohio, 43065
Complete Family Vision Care
San Diego, California, 92123
About this study
Official title: 7 Day Trial of APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism
Vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the APIOC™ for Presbyopia or the APIOC™ for Presbyopia Astigmatism contact lenses.
- Conditions
- Presbyopia, Myopia, Hyperopia, Astigmatism
- Being tested
- APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism
- Medical subject headings
- Presbyopia, Myopia, Hyperopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APIOC for Presbyopia and APIOC for Presbyopia for AstigmatismDevice
Contact Lenses for Presbyopia
| Study group | Role | What they receive |
|---|---|---|
| APIOC for Presbyopia and Presbyopia with Astigmatism | Experimental | Presbyopic Spherical or Toric Contact Lens Receives: Device: APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity Distance
High and Low Contrast LogMAR
Measured: Day 7
Subjective Vision Quality
Visual analogue scale (0-100 points) 100 is best possible quality of vision
Measured: Day 7
Comfort
Visual analogue scale(0-100 points) 100 is best possible comfort
Measured: Day 7
Visual Acuity Near
High and Low Contrast
Measured: Day 7
Visual Acuity Intermediate
High and Low Contrast
Measured: Day 7
Secondary outcomes (2)
Subjective Comfort
Compared to habitual lenses, rated as better/same/worse
Measured: Day 7
Subjective vision Comparison
Compared to habitual lenses, rated as better/same/worse
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start6 May 2021
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lentechs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Quinn, OD, MS, Principal investigator, Athens Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883099
- Sponsor's protocol ID
- LEN101
- Status last verified
- Jan 2022
- First submitted
- 4 May 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No sharing of data is planned.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7 Day Trial of APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism
- ClinicalTrials.gov ID
- NCT04883099
- Acronym / sponsor ID
- LEN101
- Conditions
- Presbyopia, Myopia, Hyperopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lentechs, LLCIndustry (pharma, biotech, devices)
- Study start
- 6 May 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the APIOC™ for Presbyopia or the APIOC™ for Presbyopia Astigmatism contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APIOC for Presbyopia and Presbyopia with Astigmatism | Experimental | Device: APIOC for Presbyopia and APIOC for Presbyopia for AstigmatismPresbyopic Spherical or Toric Contact Lens |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The subject must provide written informed consent.
- The subject must appear willing and able to adhere to the instructions set forth in this protocol.
- At least 40 years of age and no more than 70 years of age.
- ≤ 4.00 D of corneal astigmatism.
- ≤ 2.50 D of refractive astigmatism.
Key exclusion criteria (11 listed)
- Irregular corneal astigmatism.
- Corneal scarring unless off line-of-site and well healed.
- Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
- Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Occasional artificial tear use is permitted.
- Systemic disease that would interfere with contact lens wear.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APIOC for Presbyopia and APIOC for Presbyopia for AstigmatismContact Lenses for Presbyopia | Device | APIOC for Presbyopia and Presbyopia with Astigmatism |
Primary outcome
Visual Acuity Distance
Time frame: Day 7
High and Low Contrast LogMAR
Subjective Vision Quality
Time frame: Day 7
Visual analogue scale (0-100 points) 100 is best possible quality of vision
Comfort
Time frame: Day 7
Visual analogue scale(0-100 points) 100 is best possible comfort
Visual Acuity Near
Time frame: Day 7
High and Low Contrast
Visual Acuity Intermediate
Time frame: Day 7
High and Low Contrast
2 secondary outcomes
Subjective Comfort
Time frame: Day 7
Subjective vision Comparison
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: No. No sharing of data is planned.
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Clinical Trial With Artiflex Presbyopic (Artiplus)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Quinn, OD, MS principal investigator
Athens Eye Care
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism in people with Presbyopia and Myopia, run by Lentechs, LLC at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity Distance (time frame: Day 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.